Gastrointestinal Bleeding Clinical Trial
The study objective is to compare the cost-effectiveness of VCE to push enteroscopy in patients with gastrointestinal bleeding of obscure origin with a negative initial work-up.
Background: The introduction of the wireless capsule endoscopy (WCE) may dramatically alter
the management of patients with small bowel disease such as chronic gastrointestinal
bleeding of obscure origin (CGB). Yet, to date, this non invasive technique has undergone
widespread diffusion in the absence of properly designed prospective comparative
cost-effectiveness evaluations.
Objectives: To examine the clinical impact and cost-effectiveness of a novel approach
employing WCE compared to that of push enteroscopy (PE).
Hypothesis: WCE is more cost-effective than PE in patients with CGB. Study design: We
propose a randomized clinical trial comparing WCE to PE. Study population: Patients with CGB
having undergone initial normal assessment with gastroscopy, colonoscopy and radiological
examination of the small bowel.
Outcomes: Primary objective: To compare the detection rates of "clinically significant"
small bowel lesions using WCE versus PE in CGB patients randomized to either modality.
Secondary objectives: To determine the "cure rate" for each technique after 6 months, the
cost-effectiveness of WCE versus PE, the type of small bowel lesions most likely to impact
on clinical care, inter-rater variability in reading WCE examinations, the feasibility of
WCE interpretation by a dedicated technician, the safety of each imaging modality, and to
compare patient satisfaction and quality of life between the two groups.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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